Head snuggler

ABSTRACT

A device for treating or preventing plagiocephaly includes a head strap, pair of shoulder straps and a crotch strap which hold a patient&#39;s head correctly in a depression in a pillow section. The device can be custom fit to the characteristics of any person&#39;s head.

BACKGROUND

1. Field of the Invention

The invention is a device to be worn by infants and newborn children, for example, during sleep in order to prevent plagiocephaly.

2. Background of the Invention

A major concern in the development of an infant child is the flattening of his or her head brought about by the repeated positioning of the infant's head in the same position against a flat surface during sleep or rest. During development, an infant's skull is extremely soft and malleable to allow for the fast growth rate of the brain. As the brain develops, the skull must retain its malleability in order to accommodate the rapid growth. When an infant is repeatedly allowed to sleep or rest with its soft head laying against a flat surface (such as in cribs, strollers, playpen, or car seats), the force of gravity can cause the infant's head to mold to the shape of the surface at the contact region between the head and surface. The infant's head flattens, and, thus, develops what is known as positional plagiocephaly, or flattened head syndrome.

The need for effective treatment and prevention of plagiocephaly has become particularly compelling due to current medical recommendations from the American Academy of Pediatrics that infants sleep in a supine position (laying on their backs) to help prevent sudden infant death syndrome (SIDS). Although the incidence of SIDS has greatly decreased because of this recommendation, the incidence of plagiocephaly has consequently risen.

Several devices to prevent positional plagiocephaly exist in the art. These devices include a number of caps and pillow-like head supports designed to angle or support an infant's head or body. One of these devices is described by U.S. Pat. No. 6,968,586, herein incorporated by reference in its entirety. Helmets and caps (such as described by U.S. Pat. No. 6,393,316, herein incorporated by reference in its entirety) that are available are, by design, thick and bulky to allow the cushioning of the infant's head in preventing positional plagiocephaly. Because of their design, these helmets and caps place the infant's head in an unnatural and uncomfortable position and can become uncomfortably hot when worn for extended periods.

Similarly, available pillows include those having a sloped surface that causes the tilting of an infant's head. These devices, however, lack sufficient counter-support to allow natural positioning of the infant child's head without excessive effort or discomfort on the part of the infant. These pillow-type devices may be provided with one or more indentation regions.

Furthermore, conventional caps and head supports fail to provide for adjustment or customization of treatment, particularly once plagiocephaly has been diagnosed. For example, once employed, a pillow of the prior art cannot be adjusted to increase or decrease the slope angle in order to accommodate the growth of the infant's head or gradual improvement in the shape of the infant's head.

Although commercial devices currently on the market are designed to prevent instances of plagiocephaly, once such a condition is found in a child, none of these devices can be used to correct the problem with a customized solution.

SUMMARY OF THE INVENTION

In order to solve the problems of conventional systems, the head snuggler of the present invention includes a pillow section for receiving and supporting the rear of a child's head and a head strap to hold the child's head on the pillow section.

In one embodiment, the snuggler is provided with one or more shoulder straps, designed to be worn around the shoulders of the child. These shoulder straps can be used to further secure the device to the child. Additional elements, such as crotch supports, and clips can also be included, to form what is known in the art as a five-point harness.

In one preferred embodiment, in order to correct a condition of plagiocephaly, the device may be customizable. For example, once plagiocephaly has been diagnosed in a child, a mold can be taken, and a properly fitting device be manufactured therefrom.

In other embodiments, the device can be used as a treatment or preventive for other conditions. Examples of such conditions include:

-   -   a. A child or an adult with an injury or illness that would         benefit from midline head support while in a supine position,         e.g., for children in a car seat or stroller;

b. Children or adults with significant cranial burns in need of pressure relief;

-   -   c. Children or adults with head trauma and/or brain injuries,         cranial surgeries; craniotomies, locked in syndrome, edema,         stroke, bone plate removal positioning, shunt placement;     -   d. Individuals with Cerebral palsy; positioning for upright         feeding, wheel chair positioning, and/or sleeping;     -   e. Individuals with occipital pressure sores or soft tissue ear         sore from sidelying;     -   f. Individuals with tortocollis or for prevention thereof;

g. Infants in the Neonatal Intensive Care Unit; to avoid airway complication from intubation, support head in midline and in sidelying;

-   -   h. Dolicephaly prevention by supporting head in a midline         position; encouraging age appropriate development in the         hospital and/or at home;     -   i. Individuals in the Intensive Care Unit in a coma, sedated         and/or chemical paralyzed and are unable to relieve pressure         from their heads; and     -   j. Infants born with chromosomal defects that would benefit from         support while sleeping in the hospital and/or at home.

Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device according to the invention, as worn by a child.

FIG. 2 shows a preferred embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a head snuggler device 10, as worn about a forehead 12 of a child 14. In one embodiment, the device 10 includes a pillow section 16 and a single strap 18 that holds the device in place.

The strap 18 can be any conventional strap. For example, the strap 18 may include hook-and-loop pads, and/or may be formed from an elastic-type material (permitting stretching), allowing for a great deal of adjustability in the length of the strap 18. Typically, the strap 18 has a cushioning element 18 a which can be as simple as a soft pad (e.g., cotton or gauze), where the strap 18 meets the forehead.

The strap 18 is preferably positioned to hold the back of the child's head 20 in place over the pillow section 16. In a preferred embodiment (shown in FIG. 2), the pillow section 16 is provided with an indentation 22 into which the back of the child's head 20 is to be placed. Although the indentation 22 is preferably centered in the pillow section 16, such that an upper ledge 24, of equal length L, is about the indentation, such is not required.

Although FIG. 2 shows the indentation 22 has a hole, it is within the scope of the invention to provide the indentation 22 with a bottom 22 a (not shown). In such a configuration, the bottom 22 a is typically at a different elevation as compared to the upper ledge 24, in order to form the indentation 22.

If the strap 18 is positioned correctly, it is possible to have a reversible device 10, wherein the bottom is not positioned centrally in the indentation. When the device 10 is in one orientation, the bottom 22 a would be at a first distance from the (effective) upper ledge 24, and when flipped over, the bottom 22 a could be at a different distance from the (effective) upper ledge 24.

Positioned between the upper ledge 24 and the indentation 22 (or bottom 22 a) is a transition 26. FIG. 2 shows the transition 26 as being a straight section, forming a singe sharp angle (such as an approximate right angle) with the upper ledge. However, the transition may be rounded (preferably convex), tapered or connect through a number of angles and lengths (which may be equal or different).

The material for the pillow section 16 may be any type of material, but is typically soft. In one embodiment, the pillow section 16 is formed from a wire-type frame and is covered by a soft fabric covering. The covering can be removed for cleaning or replacement. The pillow section 16 can also be formed from a foamed material which would allow for a varying degree of deformation under pressure. The specific type of foam, e.g., open cell, etc., would be determined depending upon the desired properties.

It is also considered within the scope of the invention to form the pillow section 16 from an inflatable structure. In this embodiment, a port 16a (not shown) would be present on the pillow section 16 to allow for inflation, which can be performed manually (e.g., by mouth) or automatically (e.g., a pump). If the port 16a were not present, the pillow section 16 can be inflated by a gas cartridge (e.g., a carbon dioxide cartridge), configured to release its gas into the pillow section.

The device 10 typically includes other securing elements. In one embodiment, two shoulder straps 30 are positioned on opposite sides of the pillow section 16 to help prevent the child from moving off the device 10 in a lateral direction. If further securing is desired, a crotch strap can be provided, attached at a lower extension, or a chest clip can be used (which can connect to each shoulder strap). Padding and other elements can also be included, as described by U.S. Pat. No. 6,968,586.

Although the device 10 may be purchased “off the shelf,” typically the device 10 is custom designed to ensure the correct fit. Typically, this is accomplished by having the head of the child measured and the measurements transmitted to the manufacturer by, e.g., telephone, U.S. mail, electronic mail, facsimile, and the internet. For example, the manufacturer can maintain provide a website, giving both instructions for taking the measurements (which instructions can include a template) and a form for inputting the measurements and ordering the device.

The measurements can also be determined with a mold. For example, a parent or doctor can place a deformable mold on the head of the child, such that the mold mimics the shape of the child's head. The mold is then sent to the manufacturer who determines the characteristics of the child's head from the mold. In such an embodiment, the mold can be purchased at a retailer, eliminating the need for a doctor.

In one embodiment, the mold is a flexible plastic structure, such as a B-stage resin. When formed into the correct shape, the mold can be rigidified by any method known in the art. This method is similar to that which is disclosed by U.S. Pat. No. 5,874,141, herein incorporated by reference in its entirety.

It is considered within the scope of the invention to provide a number of devices in accordance with the invention. For example, if a device is purchased when a child is at a young age (such as 1 or 2 months), the device will likely not fit once the child reaches 4 or 5 months. Therefore, multiple devices, of various sized can be sold in a single package or retailers can stock devices of various sizes.

Similarly, when a device is custom designed, the manufacturer can form multiple devices of different sizes for when the child ages. Statistical information and current characteristics (e.g., measurements of different areas) can be used to anticipate or hypothesize as to the size and shape of devices for when the child ages.

In addition to correcting plagiocephaly in a child, the device of the invention can be used to treat plagiocephaly. Particularly because the device can be custom designed for use with a specific child with the child's particular condition, unlike conventional devices, the device of the invention can be formed to apply pressure in certain areas, and relieve pressures in other areas to correct plagiocephaly.

It should be apparent that embodiments other than those specifically described above may come within the spirit and scope of the present invention. Hence, the present invention is not limited by the above description. 

1. A device for treating or preventing plagiocephaly in a patient comprising: a pillow section, comprising a depressed area for supporting a rear portion of the patient's head; and a head strap, joined to the pillow section, for holding the patient's head in the depressed area; wherein the depressed area of the pillow section is sized and shaped to treat or prevent plagiocephaly.
 2. The device of claim 1, further comprising at least one of: first and second shoulder straps, joined to the pillow section, for securing the device about the shoulders of the patient and a crotch strap connected to the pillow section.
 3. The device of claim 2, wherein at least one of the first and second shoulder straps, the crotch strap and the head strap are adjustable.
 4. The device of claim 1, wherein the depressed area is custom designed to fit the patient's head.
 5. The device of claim 1, wherein the pillow section is inflatable.
 6. A method of preventing or treating plagiocephaly in a patient comprising: placing the head of the patient in a depressed area of a pillow section and securing the pillow section to the patient, comprising fastening a strap about the head of the patient, wherein the depressed area of the pillow section is sized and shaped to treat or prevent plagiocephaly.
 7. The method of claim 6, further comprising: determining characteristics of the patient's head and forming at least the pillow section according to the determined characteristics.
 8. The method of claim 7, wherein the determining step comprises forming a mold of the patient's head.
 9. The method of claim 6, comprising diagnosing plagiocephaly in the patient.
 10. The method of claim 9, further comprising: determining characteristics of the patient's head and forming at least the pillow section according to the measured characteristics.
 11. The method of claim 10, wherein the determining step comprises forming a mold of the child's head.
 12. The method of claim 6, further comprising inflating the pillow section.
 13. The method of claim 6, wherein the securing step further comprises fastening at least of a first and second shoulder strap and a crotch strap about the patient.
 14. A method of manufacturing a device for treatment or prevention of plagiocephaly in a patient comprising a pillow section, the method comprising: obtaining characteristics of the patient's head; forming a the pillow section according to the characteristics.
 15. The method of claim 14, further comprising diagnosing plagiocephaly in a patient.
 16. The method of claim 15, further comprising measuring the characteristics in the patient diagnosed with plagiocephaly.
 17. The method of claim 14, wherein the obtaining comprises analyzing a mold of the child's head.
 18. A kit comprising: a flexible mold for determining characteristics of a child's head; instructions for applying the flexible mold to the child's head; and instructions for sending the mold to the manufacturer and for ordering a device to prevent and/or treat plagiocephaly. 